Research - Laboratory/Non-Laboratory, Staff/Administrative
The primary purpose of this position is to support clinical research studies in the fields of pancreatitis and total pancreatectomy with islet autotransplantation according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new studies, coordinating the enrollment of eligible patients, performing patient evaluations, extracting and reporting accurate and high quality patient data and tissue samples, and responding to data queries. This position reports to Dr. Melena Bellin. While the position is based in Pediatrics, the research in this group enrolls both children and adult participants.
Research Evaluations/Data Management (75%) •Coordinate multiple clinical research projects as assigned •Utilize the nursing process and standards to perform protocol-specific research activities, including obtaining informed consent, conducting medical procedures, monitoring adverse events, etc •Administer medications and/or treatments as defined by the study protocols •Coordinate research subject’s recruitment, screening, enrollment, ongoing participation, follow-up, etc for assigned clinical research projects •Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue or research blood specimens. •Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts. •Provide effective back-up support to other members of the research team, which includes understanding the research portfolio of the whole team •Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. •Act as a liaison between Investigators, University departments, outside sponsors, clinical partners, collaborators, and affiliates.
Administration (10%) •Facilitate study start-up activities. This may include: reviewing protocol materials, planning specimen collection and processing, estimating needed effort, drafting order sets, informing the development of the study budget, source documents, etc. •Attends national meetings as appropriate
Regulatory (10%) •Assist with regulatory processes as needed. This may include: informing the study start-up process, informing the development of regulatory submissions & documents, providing back-up regulatory support, etc. •Understand the regulatory process to ensure trials are available for subject enrollment. •Participate in quality control and internal monitoring activities •Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
Education (5%) •Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care. •Contribute to the education of other research coordinators through training new staff, participating in mentoring opportunities, and engagement with the University clinical research community.
All required qualifications must be documented on application materials
Required Qualifications •BS degree in Nursing with at least 4 years of clinical research experience, OR Associate’s Degree in Nursing and a BA/BS in another field with at least 4 years of clinical research experience, OR a combination of related education and work experience to equal eight years •Current licensure to practice as a Registered Nurse in the State of Minnesota •Experience with patient care / contact, in a pediatric, or other acute medical setting •Ability to perform venipuncture and blood collection and processing, or willingness to be trained in these skills. •Experience with computerized data management in a healthcare setting, including electronic medical records •Computer proficiency and ability to navigate multiple software applications •Detail-oriented with exceptional organizational, planning and problem-solving skills •Ability to work independently, as a part of a team and with changing priorities •Demonstrated ability to maintain deadlines and prioritize assignments •Excellent written, verbal and interpersonal skills •During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.
Preferred Qualifications •Experience in pediatrics •Familiarity with clinical research and/or research methodology and regulations •Experience with Epic electronic medical record system •Research certification, such as CCRP or CCRC.
Internal Number: 340418
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.